A Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) for Moderate to Severe Crohn's Disease
The purpose of the HARMONY study is to assess the safety and efficacy of an investigational drug called HuZAF, in patients with moderate to severe Crohn's disease (CD). HuZAF is a humanized anti-Interferon-gamma (anti-IFN-γ) monoclonal antibody, which binds and blocks IFN-γ, a protein in the immune system that is involved in inflammation. Antibodies are proteins normally produced by our immune system to help fight off foreign substances. Scientists have been able to make therapeutic humanized monoclonal antibodies, similar to the antibodies in our bodies, to target diseases.
Digestive System Disease
Drug: anti-Interferon-gamma monoclonal antibody
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase II, Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of a Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) Administered to Patients With Moderate to Severe Crohn's Disease|
|Study Start Date:||March 2002|
|Study Completion Date:||April 2004|
|Primary Completion Date:||April 2004 (Final data collection date for primary outcome measure)|
Participants will be randomized, assigned by chance, to one of five treatment groups consisting of: four groups differing in the amount of study drug given and one placebo group. The initial dose of study drug will be given intravenously, injected into a vein in the arm. Four weeks later, three subsequent doses of study drug will be given subcutaneously, through the skin, every four weeks for three doses. Patients will be followed for approximately six months after receiving their final dose.
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